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ACT With Feedback for Post Traumatic Stress Disorder (PTSD)

Primary Purpose

PTSD

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Attention Control Training (ACT) with ABV feedback
Attention Control Training (ACT) with yoked sham feedback
Sponsored by
Tel Aviv University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, Attention Training, Cognitive Bias Modification, Attention Bias Modification

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of PTSD according to the DSM-5 and related to military service, ages 18-65

Exclusion Criteria:

  • Psychotic or Bipolar disorder, drug and alcohol abuse, other psychological treatment, vision problems that are not overcome with regular glasses, physical disability that prevents ability to operate computer.

Sites / Locations

  • Tel Aviv UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Training group - ACT with feedback

Control group - ABV with yoked sham feedback

Arm Description

At the beginning of each session participants will complete 45 standard dot-probe trials. During these trials, participants' ABV will be measured and set as their baseline. In the following trials, participants will receive feedback: a green screen background when their ABV will reach below their baseline or a red screen background when their baseline ABV score is surpassed.

Participants in this group will receive sham feedback that is unrelated to their ABV during the task, this is by presenting a feedback given to another participant in the training group (i.e., yoked sham feedback).

Outcomes

Primary Outcome Measures

Change from baseline of the total severity score of the CAPS-5 interview
The Clinician Administered PTSD Scale (CAPS-5), is a structured interview that will be used to make a diagnosis of PTSD according to the DSM-V criteria. This interview is consists of 30 items regarding the frequency and intensity of PTSD symptoms and a total score of severity is been rated, with higher scores denoting higher symptom severity.

Secondary Outcome Measures

Change from baseline of the total score of the PTSD Checklist (PCL-5)
The PCL-5, is a 20-item National Center for PTSD Checklist of the Department of Veterans Affairs. Scores can range from 0 to 80, with higher scores reflecting more symptoms of PTSD.
Change from baseline of the total score of the PHQ-9
The PHQ-9 is a 9-item scale for depression symptoms (Kroenke, Spitzer, & Williams, 2001). Scores can range from 0 to 27, with higher scores reflecting more symptoms of depression.

Full Information

First Posted
January 27, 2022
Last Updated
February 15, 2022
Sponsor
Tel Aviv University
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1. Study Identification

Unique Protocol Identification Number
NCT05242263
Brief Title
ACT With Feedback for Post Traumatic Stress Disorder (PTSD)
Official Title
Reducing Attention Bias Variability Using Attention Control Training With Feedback Among Individuals With Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 12, 2019 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to explore the efficacy of Attention Control Training with the inclusion of feedback for Post Traumatic Stress Disorder (PTSD). It seems that the most efficient ABMT method to balance attention bias variability (ABV) among individuals with PTSD is Attention Control Training (ACT). This type of training is designed to balance attention allocation towards threat-related and neutral stimuli. A few studies have further shown that this training type succeeds in balancing the aberrant fluctuations in attention bias observed in patients with PTSD, and that this leads to a reduction in PTSD symptoms (Badura-Brack et al., 2015). The purpose of the current study is to examine the efficacy of ACT that also includes feedback. Specifically, we intend to test whether the inclusion of feedback on top of standard ACT may enhance training efficacy in reducing ABV and in reducing PTSD symptoms.
Detailed Description
The aim of the current study is to explore the efficacy of Attention Control Training with the inclusion of feedback for Post Traumatic Stress Disorder (PTSD). Individuals with PTSD exhibit increased threat-related attention bias variability (ABV; Lacoviello et al., 2014; Naim et al., 2015). Based on these findings, computerized training methods aimed to modify the attention bias were developed (Attention Bias Modification Training; ABMT). It seems that the most efficient ABMT method to balance ABV among individuals with PTSD is Attention Control Training (ACT). This type of training is designed to balance attention allocation towards threat-related and neutral stimuli. A few studies have further shown that this training type succeeds in balancing the aberrant fluctuations in attention bias observed in PTSD, and that this leads to a reduction in PTSD symptoms (Badura-Brack et al., 2015). The purpose of the current study is to examine the efficacy of ACT that also includes a feedback component. Specifically, we intend to test whether the inclusion of feedback on top of standard ACT may enhance training efficacy in reducing ABV and in reducing PTSD symptoms. For this purpose, we will recruit 60 IDF veterans diagnosed with PTSD that will be randomly assigned to one of two conditions: ACT with feedback or ACT with yoked sham feedback. We expect that ACT with feedback will produce greater reduction in PTSD symptoms and in ABV relative to ACT with yoked sham feedback.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
PTSD, Attention Training, Cognitive Bias Modification, Attention Bias Modification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to either active or sham feedback in a 1:1 ratio.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Study design is a double-blind parallel-group RCT: two groups (ACT+feedback and ACT+sham feedback), and two assessment time points (pre- and post-treatment). The independent clinical evaluators, personnel staff who deliver the training, and participants are blind before and during treatment to group allocation, which is coded with a random number for each condition. Participants are randomly assigned to conditions in a 1:1 ratio using a list created with a random number generator. The random assignment list was created before enrollment to the study started. Group assignment is monitored by a staff member not involved in the study in any other capacity.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training group - ACT with feedback
Arm Type
Experimental
Arm Description
At the beginning of each session participants will complete 45 standard dot-probe trials. During these trials, participants' ABV will be measured and set as their baseline. In the following trials, participants will receive feedback: a green screen background when their ABV will reach below their baseline or a red screen background when their baseline ABV score is surpassed.
Arm Title
Control group - ABV with yoked sham feedback
Arm Type
Sham Comparator
Arm Description
Participants in this group will receive sham feedback that is unrelated to their ABV during the task, this is by presenting a feedback given to another participant in the training group (i.e., yoked sham feedback).
Intervention Type
Behavioral
Intervention Name(s)
Attention Control Training (ACT) with ABV feedback
Intervention Description
At the beginning of each session, participants will complete 45 standard dot-probe trials as described above. Participants' ABV on these trials will be calculated and set as their personal baseline (see below for ABV calculation). In the following 165-training trials, participants will receive feedback: when their online-calculated ABV will be below their baseline screen background will be green whereas its color will be red when their online ABV score will be higher than their baseline. Patients will be instructed to try to keep the background green for as long as possible.
Intervention Type
Behavioral
Intervention Name(s)
Attention Control Training (ACT) with yoked sham feedback
Intervention Description
Participants in this group will be exposed to the same task as in the active group but will receive sham feedback that is unrelated to their ABV during task performance. They will be presented with a feedback that is yoked to the one given to a participant in the training group.
Primary Outcome Measure Information:
Title
Change from baseline of the total severity score of the CAPS-5 interview
Description
The Clinician Administered PTSD Scale (CAPS-5), is a structured interview that will be used to make a diagnosis of PTSD according to the DSM-V criteria. This interview is consists of 30 items regarding the frequency and intensity of PTSD symptoms and a total score of severity is been rated, with higher scores denoting higher symptom severity.
Time Frame
Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
Secondary Outcome Measure Information:
Title
Change from baseline of the total score of the PTSD Checklist (PCL-5)
Description
The PCL-5, is a 20-item National Center for PTSD Checklist of the Department of Veterans Affairs. Scores can range from 0 to 80, with higher scores reflecting more symptoms of PTSD.
Time Frame
Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
Title
Change from baseline of the total score of the PHQ-9
Description
The PHQ-9 is a 9-item scale for depression symptoms (Kroenke, Spitzer, & Williams, 2001). Scores can range from 0 to 27, with higher scores reflecting more symptoms of depression.
Time Frame
Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
Other Pre-specified Outcome Measures:
Title
Post-Training Attention Bias Variability
Description
Change in Attention Bias Variability from Baseline to Post-training measurement and follow-up. ABV is calculated in four steps: 1) a trial-by trial moving average algorithm computed reaction times for all successive 10 neutral trial blocks and all successive 10 threat trial blocks, 2) successive attention bias scores were calculated by subtracting the first threat block average from the first neutral block average, the second threat block average from the second neutral block average, etc., forming a series of consecutive attention bias scores, 3) the standard deviation of these successive bias scores was then calculated, providing an index of variation in attention bias throughout the session, and 4) this standard deviation score was divided by the participant's mean overall reaction time
Time Frame
Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
Title
The Credibility/Expectancy Questionnaire (CEQ)
Description
The Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000). This instrument consists of 6 items which derive two factors: expectancy for change and treatment credibility. This CEQ will be used to explore whether expectancies or treatment credibility are related to outcomes.
Time Frame
Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
Title
The CGI-I
Description
Severity and improvement scale (CGI-I) will be used to assess participants global clinical condition. The CGI-I is single-item, clinician-reported, measure assessing severity and improvement of illness using a 7-point Likert-type scale.
Time Frame
1 week post treatment, and 3-months follow-up post treatment
Title
The CGI-S
Description
Severity and improvement scales (CGI-S ) will be used to assess participants global clinical condition. The CGI-S is single-item, clinician-reported, measure assessing severity and improvement of illness using a 7-point Likert-type scale.
Time Frame
1 week post treatment, and 3-months follow-up post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of PTSD according to the DSM-5 and related to military service, ages 18-65 Exclusion Criteria: Psychotic or Bipolar disorder, drug and alcohol abuse, other psychological treatment, vision problems that are not overcome with regular glasses, physical disability that prevents ability to operate computer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yair Bar-Haim, Prof.
Phone
+972-3-6405465
Email
yair1@post.tau.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Mai Gelman, MA
Phone
+972-3-6405465
Email
maigelman@mail.tau.ac.il
Facility Information:
Facility Name
Tel Aviv University
City
Tel Aviv
ZIP/Postal Code
6997801
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mai Gelman, MA
Phone
+972-3-6405465
Email
maigelman@mail.tau.ac.il

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26206076
Citation
Naim R, Abend R, Wald I, Eldar S, Levi O, Fruchter E, Ginat K, Halpern P, Sipos ML, Adler AB, Bliese PD, Quartana PJ, Pine DS, Bar-Haim Y. Threat-Related Attention Bias Variability and Posttraumatic Stress. Am J Psychiatry. 2015 Dec;172(12):1242-50. doi: 10.1176/appi.ajp.2015.14121579. Epub 2015 Jul 24.
Results Reference
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PubMed Identifier
26206075
Citation
Badura-Brack AS, Naim R, Ryan TJ, Levy O, Abend R, Khanna MM, McDermott TJ, Pine DS, Bar-Haim Y. Effect of Attention Training on Attention Bias Variability and PTSD Symptoms: Randomized Controlled Trials in Israeli and U.S. Combat Veterans. Am J Psychiatry. 2015 Dec;172(12):1233-41. doi: 10.1176/appi.ajp.2015.14121578. Epub 2015 Jul 24.
Results Reference
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ACT With Feedback for Post Traumatic Stress Disorder (PTSD)

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